FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial

Trial Title: FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial

NCT ID: NCT06201065

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Leucovorin
Oxaliplatin
Fluorouracil
Lenvatinib

Conditions: Keywords:
hepatocellular carcinoma
Lenvatinib
Oxaliplatin, Fluorouracil and Leucovorin
Hepatic arterial infusion chemotherapy
Toripalimab

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Hepatic arterial infusion chemotherapy
Description: administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Arm group label: Control arm
Arm group label: Experimental arm

Intervention type: Drug
Intervention name: Lenvatinib
Description: 12 mg (or 8 mg) once daily (QD) oral dosing
Arm group label: Control arm
Arm group label: Experimental arm

Intervention type: Drug
Intervention name: Toripalimab
Description: 240 mg iv.drip Q3W
Arm group label: Experimental arm

Intervention type: Drug
Intervention name: oxaliplatin , fluorouracil, and leucovorin
Description: FOLFOX-HAIC
Arm group label: Control arm
Arm group label: Experimental arm

Summary: Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) - Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. - Barcelona clinic liver cancer-stage C - Eastern Cooperative Oncology Group performance status of 0 to 2 - With no previous treatment - No Cirrhosis or cirrhotic status of Child-Pugh class A only - Not amendable to surgical resection ,local ablative therapy and any other cured treatment. - This study did not limit HBV DNA load. High HBV-DNA load was aollowed, but hepatitis-B patient must receive concurrent antiviral therapy. - The following laboratory parameters: Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: - Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy - Known history of HIV - History of organ allograft - Known or suspected allergy to the investigational agents or any agent given in association with this trial. - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Evidence of bleeding diathesis. - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. - Known central nervous system tumors including metastatic brain disease

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Center Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Ming Shi, MD

Phone: 8620-87343115
Email: shiming@mail.sysu.edu.cn

Start date: December 26, 2023

Completion date: December 26, 2026

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06201065